BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 9938054 · Received April 8, 2020

    Report

    Report Number
    1723170-2020-01175
    Event Type
    Death
    Date Received
    April 8, 2020
    Date of Event
    October 1, 2019
    Report Date
    April 8, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS THE MEAN VALUE OF PATIENT IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DATE OF DEATH IS THE ACCEPTED DATE OF PUBLICATION AS THE ARTICLE DID NOT SPECIFY THE DATE OF DEATH. EVENT DATE IS THE ACCEPTED DATE OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: ANASTASIOS GIAMOURIADIS, DURANKA PERERA, AFSHAN SAFDAR, FRANCESCO VERGANI, RANJEEV BHANGOO, RICHARD GULLAN, & KEYOUMARS ASHKAN. SAFETY AND ACCURACY OF FRAMELESS ELECTROMAGNETIC-NAVIGATED (AXIEM)-GUIDED BRAIN LESION BIOPSIES: A LARGE SINGLE-UNIT STUDY. ACTA NEUROCHIRURGICA (2019) 161: 2 87¿5 259 3 HTTPS://DOI.ORG/10.1007/S00701-019-04093-Y ABSTRACT: BACKGROUND: BRAIN BIOPSIES ARE REQUIRED TO ESTABLISH A DEFINITIVE HISTOLOGICAL DIAGNOSIS FOR BRAIN LESIONS THAT HAVE BEEN IDENTIFIED ON IMAGING IN ORDER TO GUIDE FURTHER TREATMENT FOR PATIENTS. OBJECTIVE: VARIOUS NAVIGATION SYSTEMS ARE IN USE BUT LITTLE UP TO DATE EVIDENCE IS AVAILABLE REGARDING THE SAFETY AND ACCURACY OF A FRAMELESS, ELECTROMAGNETIC TECHNIQUE TO TARGET BRAIN LESIONS. METHODS: DATA WAS COLLECTED RETROSPECTIVELY ON ALL PATIENTS THAT HAD BRAIN BIOPSIES AT OUR INSTITUTION FROM 01/01/2010 TO 31/12/2017. OPERATION NOTES, NEUROPATHOLOGY REPORTS, AND CLINICAL NOTES ON ELECTRONIC PATIENT RECORD WERE USED TO DETERMINE WHETHER BIOPSY OF ADEQUATE IDENTIFIABLE ABNORMAL TISSUE WAS ACHIEVED, WHETHER A DEFINITIVE DIAGNOSIS WAS ESTABLISHED, ANY ADVERSE EVENTS OCCURRED, AND IF A REPEAT BIOPSY WAS CARRIED OUT. RESULTS THREE HUNDRED SEVENTY-ONE AXIEM(MEDTRONIC, MINNEAPOLIS, USA)-GUIDED BRAIN TUMOR BIOPSIES WERE PERFORMED IN THIS 8-YEAR PERIOD. THREE HUNDRED FORTY-NINE (94.07%) PROCEDURES PROVIDED DEFINITIVE TISSUE DIAGNOSIS, 22 (5.93%) WERE NON DIAGNOSTIC; IN 6 CASES (1.62%), REPEAT BIOPSY WAS PERFORMED AND ADVERSE EVENTS WHICH CAUSED CLINICAL COMPROMISE WERE OBSERVED IN 4 PATIENTS (1.08%). CONCLUSIONS THE AXIEM IS A FAST, EFFECTIVE, AND SAFE FRAMELESS AND PINLESS NEURONAVIGATIONAL SYSTEM. IT OFFERS A HIGH DEGREE OF ACCURACY REQUIRED FOR THE ESTABLISHMENT OF A DEFINITIVE DIAGNOSIS, PERMITTING OPTIMAL FURTHER TREATMENT, AND THUS IMPROVING PATIENT OUTCOMES. REPORTED EVENTS: 1. THREE PATIENTS DIED FROM POSTOPERATIVE HEMATOMA AND CEREBRAL EDEMA IN THE REGION OF THE BIOPSY TRACT WITHIN 24 HOURS. IT WAS NOTED THE PATIENTS HAD A DIAGNOSIS OF GLIOBLASTOMA MULTIFORME IV. 2. ONE PATIENT DIED FROM NEW ONSET POSTOPERATIVE STATUS EPILEPTICUS. IT WAS NOTED THAT THE PATIENT HAD DIFFUSE B CELL LYMPHOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405192 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death